Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Phase 1CompletedNCT00920998

Astellas Pharma Inc30 enrolled

Overview

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Z-338DRUG

oral

Eligibility

Sex: MALEMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subject * Body weight: 50.0 - 80.0 kg * BMI: 17.6 - 26.4 Exclusion Criteria: * Receiving an investigational new drug within 120 days of the study * Receiving medical treatment drugs within 7 days of the study * Blood donation before the study

Locations (1)

Unnamed facility

Kyushu, Japan

Outcomes

Primary Outcomes

Pharmacokinetics of Z-338

Time frame: 48 hours

Data from ClinicalTrials.gov

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